The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST) trial for stroke: study design and protocol

Abstract

Methods: Persons ≥ 3 months poststroke are randomized to wear either FDS or AFO for 30 weeks. After 30 weeks, AFO participants crossover to wear an FDS. All participants are followed for 42 weeks with repeated measures at baseline and Weeks 6, 12, 30, 36, and 42. The primary analysis will compare gait speed between FDS and AFO at 30 weeks. Secondary outcomes span the International Classification of Functioning, Disability, and Health categories and include functional gait, balance, motor control, falls, and quality of life. Tertiary analyses will be performed using Weeks 36 and 42 time points. Conclusion: This pivotal trial is the first longitudinal randomized controlled trial to compare FDS and AFO in persons with stroke. Further, the results will be the largest single contribution to date on the efficacy of FDS in people with stroke, providing a robust dataset with findings that can be extrapolated for use as guidelines to clinical practice. Trial registration: clinicaltrials.gov NCT01138995. Keywords: electrical stimulation, stroke, cerebrovascular accident, rehabilitation, foot drop stimulation, gait